DE212006000063U1 - Device for detecting analytes in liquid samples - Google Patents

Device for detecting analytes in liquid samples

Info

Publication number
DE212006000063U1
DE212006000063U1 DE212006000063U DE212006000063U DE212006000063U1 DE 212006000063 U1 DE212006000063 U1 DE 212006000063U1 DE 212006000063 U DE212006000063 U DE 212006000063U DE 212006000063 U DE212006000063 U DE 212006000063U DE 212006000063 U1 DE212006000063 U1 DE 212006000063U1
Authority
DE
Germany
Prior art keywords
chamber
test
zone
device
liquid sample
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
DE212006000063U
Other languages
German (de)
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Inverness Medical Switzerland GmbH
Original Assignee
Inverness Medical Switzerland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to CN200510113977.5 priority Critical
Priority to CNB2005101139775A priority patent/CN100478671C/en
Priority to US11/260,496 priority
Priority to US11/260,496 priority patent/US9011770B2/en
Application filed by Inverness Medical Switzerland GmbH filed Critical Inverness Medical Switzerland GmbH
Priority to PCT/GB2006/003910 priority patent/WO2007049010A1/en
Publication of DE212006000063U1 publication Critical patent/DE212006000063U1/en
Anticipated expiration legal-status Critical
Application status is Expired - Lifetime legal-status Critical

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366Apparatus specially adapted for solid-phase testing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • A61B10/007Devices for taking samples of body liquids for taking urine samples
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/06Auxiliary integrated devices, integrated components
    • B01L2300/0627Sensor or part of a sensor is integrated
    • B01L2300/0663Whole sensors
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0861Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/087Multiple sequential chambers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/04Moving fluids with specific forces or mechanical means
    • B01L2400/0475Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0478Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure pistons
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/25Chemistry: analytical and immunological testing including sample preparation
    • Y10T436/2575Volumetric liquid transfer

Abstract

Apparatus for detecting the presence of an analyte in a liquid sample, comprising:
an opening for introducing the liquid sample into a first chamber for collecting the liquid sample;
a second chamber connected to the first chamber through a passageway and containing a test element;
a third chamber connected to the second chamber through a channel and including a movable member having first and second positions, the third chamber being divided by the movable member into first and second zones and the first zone including a vent hole;
wherein the movable member is in contact with at least one wall of the third chamber to prevent gas communication between the first and second zones.

Description

  • Field of the invention
  • The The present invention relates to devices for detection (measurement) of analytes in liquid samples.
  • Background of the invention
  • Of the The following background of the invention serves to assist the reader in understanding The invention is not to be considered as a prior art.
  • in the Healthcare is the diagnostic testing of body fluids an everyday activity. Increasingly, too Employers, government agencies, sports teams and other organizations involved in diagnostic testing, to maintain job security and compliance To ensure laws, rules and regulations.
  • It is generally necessary to provide devices for collecting body fluids such as. Urine and to detect the presence of a particular analyte (eg, a drug and / or its metabolite, or a disease indicator). Such test devices generally require that a sample be placed in a sample container and that a technician manually insert and submerge a portion of a test strip into the sample and then pull it out to read the result. Because of the potential contact of the technician with the sample and the associated health and contamination risks, a sealed container to avoid contact is desirable. Various remedies have been proposed to reduce the risk of contact, as described in U.S. Patent No. 4,976,923 , the U.S. Patent No. 5,429,804 and the U.S. Patent No. 6,726,879 which test devices use test strips mounted in their lids. In use, the container is turned over or tilted so that the sample can wet the strips to perform the test.
  • Recently has the use of test devices by persons other than Health professionals increased. Due to the fact that these Tests increasingly carried out by relatively unqualified technicians and evaluated, the device should be easy to use to ensure adequate immersion of the test strip and deliver accurate results.
  • Therefore There is a continuing need for test devices that are a minimum require manual operation while being accurate and accurate Ensure reliable test results.
  • Presentation of the invention
  • The The present invention provides a device for detecting the Presence of an analyte in a liquid sample ready. The device has an opening for insertion the liquid sample into a first chamber for collecting the liquid sample and a second chamber connected to the first chamber is connected through a passage and contains a test element. The device also has a third chamber with the second Chamber is connected by a channel and a movable element Contains a first and a second position. The third chamber is moved from the movable element into a first and second Divided zone, and the first zone has a ventilation hole. The movable element is located with at least one wall of the third chamber in contact to a gas connection between the first and second zone.
  • In In one embodiment, the device may also include a lid to close the opening. The test element may be a sample card containing one or more sample test strips contains.
  • In an embodiment of the device is the movable Element a piston. The piston may be one with at least one Wall of the third chamber containing seal in contact a gas connection between the first and second zone of the third Chamber to prevent. The third chamber may also have a bottom, and in one embodiment, the vent hole is located on the floor of the third chamber. In one embodiment the piston has a push rod extending to the opening the container extends. The lid can have a surface own who touches the push rod and pushes down, when the lid is applied to the opening.
  • In various embodiments of the device has the passage has a diameter of less than 10 mm or less as 9 mm or less than 8 mm or less than 7 mm or less as 6 mm or less than 5 mm or less than 4 mm or less than 3 mm.
  • In another aspect, the present invention provides methods for detecting the presence of an analyte in a liquid sample. The methods include loading a liquid sample into a test device as described herein, causing the movable member to move from the first position to the second position, thereby causing an air volume, from the second chamber to the third chamber to be sucked and thereby cause a volume of liquid to be sucked through the passageway from the first chamber into the second chamber to contact the test element and to detect the presence of the analyte in the sample.
  • In In one embodiment, the methods include touching the lid with the push rod and the pressing down of the Push rod when the lid is applied to the device, and the resulting cause of the movable element, to move from the first position to the second position. In one embodiment, this depresses the push rod and moving the movable member from the first to the second position, that is a negative air pressure gradient formed in the third chamber and that an air volume from the second chamber is sucked into the third chamber. The movement of the Air volume from the second chamber to the third chamber, the Cause of the formation of a negative air pressure gradient in the be the second chamber. With formation of a negative air pressure gradient is meant that in a chamber forms a vacuum (vacuum), causing air from another chamber to enter the Chamber "pulled" to fill the vacuum generated. The air pressure gradient refers to a difference of the internal Air pressures between the two chambers.
  • In In one embodiment, the negative air pressure gradient causes in the second chamber, that the liquid sample from the first chamber flows through the passage into the second chamber and while touching the test element. The depressing the push rod and moving the movable member from the first position in the second position can cause a Air volume through the vent hole from the first zone escapes.
  • The Presentation of the invention described above is not limiting and other features and advantages of the invention will become apparent from the following detailed description and apparent from the claims become.
  • Brief description of the drawings
  • 1 is an exploded perspective view of the device according to the present invention.
  • 2 Figure 11 is another exploded perspective view of the device according to the present invention from a different angle.
  • 3 is a perspective view of the device according to the present invention with the lid removed.
  • 4 is a perspective view of the device according to the present invention with the floor removed.
  • 5 Figure 10 is a cross-sectional view of the device of the present invention with a liquid sample received in both the first and second chambers.
  • 6 is an enlarged partial view of the 5 wherein the liquid sample is not shown to more clearly illustrate the structure of a passageway.
  • 7 FIG. 12 is a cross-sectional view of the device according to the present invention showing that a piston is positioned in a first position and the liquid sample is received only in the first chamber. FIG.
  • 8th is an enlarged partial view of the 7 wherein the liquid sample is not shown to more clearly illustrate the structure of a channel.
  • 9 is a cross-sectional view similar to the 7 wherein the piston is positioned in a second position and a portion of the fluid sample has flowed into the second chamber.
  • Detailed description
  • The The present invention provides apparatus and methods for detection the presence or amount of an analyte in a liquid Sample ready. In one embodiment, the device takes the shape of a cup, which is a liquid sample for analysis. In one embodiment, the liquid sample urine. The analyte can be any analyte, For example, glucose, a drug / drug or a metabolite thereof.
  • The device uses a system of chambers to move the liquid sample through the device and detect the presence or amount of an analyte in the samples. In one embodiment, the device has three chambers, and the liquid sample can be moved from one chamber to the other by means of air pressure. The surface tension of the liquid sample may be used to hold the liquid in a chamber until the user is ready to move the sample to an adjacent chamber by applying air pressure to the chambers. In various embodiments, the air pressure may take the form of an increase or a decrease (eg, the formation of a negative pressure) of the internal Assume air pressure. The different chambers of the device are connected by passages, channels and vent holes which allow the transfer of air pressure and liquid between the chambers. The device also has a movable element located in one of the chambers. In one embodiment, the movable member is a piston and the chamber is a cylinder in which the piston is housed. As the piston is moved from a first position to a second position, air is forced out of the third chamber and creates a vacuum that is transferred to the second chamber, causing a break in the surface tension of the liquid in the first chamber and thereby causes liquid to flow from the first to the second chamber. By cylinder is meant a structure which contains the movable element and in which the movable element is moved from a first position to a second position. If the chamber is a cylinder, it does not have to have a perfectly cylindrical shape in all embodiments, but may vary in shape and size, or assume one shape on one part and another shape on another part, as long as they are still those of the Performing the assay (s) required functions.
  • In According to one embodiment, the test element is the Device in the second chamber, and therefore begins the analysis the liquid sample. In the illustrated in the figures Embodiment, the movable member has the shape of a piston-like structure with a generally cylindrical shape. however may be the movable element in other embodiments take any suitable form.
  • analytes
  • A variety of analytes may be detected and quantified by the test elements in the present invention. The analyte may be an infectious agent or an indication of an infected condition. The analyte may be a drug (eg, a drug), a hormone, a protein, a nucleic acid molecule, an ethiological agent or a specific binding pair member. The term "drug of abuse" (DOA) refers to a drug taken for non-medical reasons (usually due to mind altering effects) .The abuse of such drugs can lead to physical and mental damage and (in some substances) to Dependency, addiction and / or death Examples of DOAs include cocaine, amphetamines (eg black beauties, white bennies, dextroamphetamines, dexies, beans), methamphetamines (Crank, Meth, Crystal, Speed), barbiturates ( Valium® , Roche Pharmaceuticals, Nutley, New Jersey); sedatives (ie, sleep aids); lysergic acid diethylamide (LSD); depressants (Downers, Goofballs, Barbs, Blue Devils, Yellow Jackets, Ludes); tricyclic antidepressants (PCA), eg, imipramine, Amitriptiline and doxepin), phencyclidine (POP), tetrahydorcannabinol (THC, kif, marijuana, hash, grass, etc.); and opiates (eg, morphine, opium, codeine, heroin, oxycodone) Reasons are taken at However, where overdose can easily occur can also be tested using these test strips, z. For example, tricyclic antidepressants (imipramine and the like) and over-the-counter products containing acetaminophen.
  • test elements
  • When Test element can be conveniently selected lateral flow test strips which are widely used to cover a wide range of To test analytes. However, any suitable test element in the can be used in the present invention.
  • A Variety of test elements may be in the present invention be incorporated. One type of test element is a test strip. Test strips are available in a variety of formats, such as The immunoassay or chemical assay format, to analytes of interest in a sample to capture, such. B. a drug or a metabolite that shows signs of health gives. Test strips may also be either for non-competitive or competitive assay formats. For some formats The test strips have a highly absorbent material with a Sample application zone, a reagent zone and a test result zone. The sample is applied to the sample application zone and flows by capillary action into the reagent zone. Dissolves in the reagent zone the sample and mixes with the reagents used for detection of the analyte (if any) are necessary. The sample, now carries the reagents, flows on to the test result zone. Additional reagents are immobilized in the test result zone, such as B. a specific binding molecule for the analyte. These reagents react with the analyte (if present) and bind him or one of the first reagents from the Reagent. Markers for providing the measurable signal may be present in the reagent zone or in one separate marking zone.
  • typically, In non-competitive formats, a signal is generated when the Sample contains the analyte, and no signal is generated when the analyte is absent. In competitive formats one can Signal are generated when no analyte is present, and no Signal if the analyte is present.
  • If the test element is a test strip, it can be made from highly absorbent or non-absorbent be produced bierendem material. A test strip may comprise more than one material, which are then in fluid communication. A material of a test strip can be placed on another material of the test strip, such. B. filter paper, which is placed on nitrocellulose. Alternatively or additionally, a test strip may comprise a region of one or more materials followed by a region of one or more different materials. In this case, the regions are in fluid communication and may or may not partially overlap one another. The material or materials of the test strip may be bound to a support or a solid surface, such as. B. a bearing plastic layer to increase their handling strength.
  • In Embodiments in which the analyte by a signal generation system is detected, such. By one or more enzymes specific to can react to the analyte, one or more components of the signal generation system in the same way to the analyte detection zones of the test strip material, such as those described above specific binding elements attached to the test strip material become. Alternatively or additionally, components may be used of the signal generation system used in the sample application zone, the Reagent zone or the analyte detection zone of the test strip available or are contained throughout the test strip, in one or more materials of the test strip impregnated become. This can be achieved either by the surface application solutions of such components or by immersion of the one or more test strip materials in solutions such components. After one or more applications or one or multiple dips becomes the test strip material dried. Alternatively or additionally Components of the signal generation system that are present in the sample application zone, the reagent zone or analyte detection zone of the test strip are present or contained anywhere in the test strip are on the surface of one or more test strip materials of the test strip are applied as for the marked Reagents has been described.
  • The zones can be arranged as follows:
    Sample application zone, one or more reagent zones, one or more test result determination zones, one or more control zones, one or more adulteration zones and a fluid-absorbing zone. If the test result determination zone has a control zone, it preferably follows the analyte detection zone of the test result determination zone. All of these zones or combinations thereof can be provided on a single strip of a single material. Alternatively, the zones are made of different materials and are connected to each other in fluid communication. For example, the different zones may be in direct or indirect fluid communication. In this case, the different zones may be connected end-to-end to be in fluid communication, overlapped to be in fluid communication, or connected by some other element, such as the like. B. a connecting material, which is preferably highly absorbent, such. As filter paper, glass fibers (glass wool) or nitrocellulose. When using a bonding material, the bonding material may include fluid from the end-to-end bonded zones or materials containing such zones, end-to-end bonded zones, or materials containing such zones that are not in fluid communication, or bonding zones or materials containing such zones contained and overlapped (for example without limitation from top to bottom), but are not in fluid communication transmitted.
  • devices
  • Mi relation to 1 and 2 For example, the device of the invention may be used to deliver a body fluid, such as a fluid. B. collecting urine and detecting the presence or amount of an analyte contained therein (eg, a drug and / or a metabolite thereof). The device generally comprises a container 111 with an opening 115 to collect the liquid sample, a lid 101 for closing the opening and at least one test element 137 to do a test. In one embodiment, the lid 101 may be a lid which is screwed tightly onto the device, however, in other embodiments the lid may be snapped or otherwise securely fastened by any suitable means. The device can also be a seal 109 to seal the container when the lid 101 is applied. In the first container 111 a movable element is provided, such. B. a piston 149 that in the tank 111 is movably recorded.
  • The parts of the device may be molded or cast from any suitable material. For example, a variety of plastics can be used. With reference to the embodiments illustrated in the figures, the device comprises a cup-like main body 111 and a base 151 attached to a floor of the main body 111 hermetically attached. Regarding 3 . 5 . 7 and 9 owns the main body 111 a number of interconnected vertical side walls 117 , where a round top edge 113 connecting the upper ends of the side walls, and a generally flat bottom wall 207 that connects the lower ends of the side walls. In In this embodiment, two inner walls extend 309 generally parallel to the two adjacent side walls 117 and connect to them at their upper ends, so to a second chamber 601 to define that contains the test element. The upper edge 113 defines an opening 115 for introducing the liquid sample and may have threads which, during coupling of the lid to the container 313 fitting with appropriate threads on the lid 101 can intervene.
  • The device has a movable element which, in certain chambers of the device, can create a negative air pressure when moved from a first to a second position. In the embodiment shown in the figures, the movable element is a piston 149 , A piston housing 111 is inside the main body 111 trained and located with the second chamber 211 containing the test element in air communication. The piston housing 311 forms the third chamber. In this embodiment, the piston housing 311 shaped like a reverse funnel and includes a lower cylindrical section 303 that is on the bottom wall 207 of the main body 111 through a ventilation hole opens. The piston housing also has an upper cylindrical portion 307 , which has a smaller diameter than the lower section 303 owns, as well as a tapered intermediate section 305 that connects the upper and lower sections. As in 7 and detailed in 8th is shown, in this embodiment, the lower portion 303 the piston housing partially with one of the inner walls 309 connected, and a channel 801 is formed in the connection area to allow air exchange between the third chamber 701 and the second chamber 601 to allow. By having the two chambers in "air communication" or "gas communication", it is meant that changing the air pressure in one chamber will cause a change in the air pressure in the other chamber or will cause fluid to escape from a chamber the other is sucked or vice versa, or that air is able to move between the two (or more) chambers.
  • chambers
  • The Chambers of the device can be any shape or design own, which is suitable to their function in the device to fulfill. In one embodiment, the third chamber a generally cylindrical, syringe-like or funnel-shaped shape but other forms can be used, the movable element and the first and second zones of the third Carry chamber. Also, the different zones of the third chamber take different forms. On similar Way the second chamber can take any shape, the test elements carries, and the first chamber can have any shape, the the introduction of liquid into the device supported.
  • The bottom wall 207 of the main body (which forms the bottom of the first chamber) contains a passage 205 in it, the first chamber with the second chamber 601 combines. The passage 205 has a diameter that is too small to allow the fluid in the main body 111 to allow it to flow through under atmospheric pressure, which is substantially equal to the atmospheric pressure. Fluid will flow from the first chamber into the second chamber under a negative pressure of air induced by the movement of the movable member. In various embodiments, the diameter of the passage is less than 10 mm or less than 9 mm or less than 8 mm or less than 7 mm or less than 6 mm or less than 5 mm or less than 4 mm or less than 3 mm or even more fewer. In one embodiment, the diameter of the passage is 205 about 4 mm or about 5 mm or about 3 mm or 3 to 5 mm. While in the illustrated embodiment the passage is an opening between the first and second chambers, the passage may also have other configurations. For example, in various embodiments, the passage may be a tortuous (wave-shaped) groove defined in the bottom wall of the main body with a small cross-sectional diameter, or any opening or passage connecting the two chambers. The bottom wall 207 further includes an embossment on its lower surface 209 around the open area.
  • The base 151 Can be permanent on the main body 111 be attached. The base 151 includes a top wall 153 , a lower wall 213 and a fencing wall 155 that the upper wall 153 and the bottom wall 213 combines. The fencing wall 155 and the bottom wall 213 define a cavity together 157 who is part of the second chamber 601 is and absorbs part of the liquid sample. In this embodiment, a groove 159 in a top of the fencing wall 155 trained to emboss with 209 on the bottom wall 207 of the main body. When assembling the main body 111 and the base 151 can the imprinting 209 in the groove 159 and then ultrasonic welding can be used to hermetically seal these two components. Various other methods may also be used to secure the base and main body together while ensuring a good seal therebetween. In various embodiments, thermal welding, gluing or pressure sealing rings may be used. The base 151 further comprises spaced retaining walls 161 for holding the test element, a block wall 163 to block fast-flowing fluid (rapid rate fluid) and one in the top wall 153 defined ventilation hole 165 , The performance and function of the retaining walls, the block wall and the ventilation hole will be described in detail below.
  • The lid 101 can with the container 313 coupled to seal the sample in the container. In addition, in the present invention, the coupling of the lid 101 can also be used on the container to begin an assay, which will be described in more detail below. In this embodiment, the lid comprises 101 a top 103 and a downwardly extending flange 105 which has a shape that matches the shape of the edge 113 of the container 313 corresponds so that the flange can be coupled to the edge. In the illustrated embodiment, the top is 103 with a circular depression 107 formed, which has a lower surface 201 owns which the moving element 215 can press down while the lid 101 to the container 313 is coupled. A sealing element 109 , such as B. an O-ring, can between the lid 101 and the container 313 be positioned to provide a seal therebetween.
  • The test element may be in the form of a test card, which may be any type of device configured to examine a sample. In this embodiment, the test element comprises a probe card (assay card) 119 for detecting the presence or amount of an analyte in the sample, and the apparatus further comprises a falsification test card 131 to record the contamination of the sample. Every card 119 ( 131 ) has such a shaped size and shape that it is in an upper portion 211 the second chamber 601 the device is used and the retaining walls 161 the base 151 is held. In other embodiments, the card may be from any suitable means in the second space 601 being held. In various embodiments, each card 119 ( 131 ) a plate 121 ( 133 ) with a group of slots defined therein 123 ( 135 ), a number of sample strips held in the slots 125 or adulteration strips 137 and a cover 127 ( 139 ) adhered to a surface of the plate and windows 129 ( 141 ) for observing the test result.
  • The moving element 215 is movable in the piston housing 311 available. In this embodiment, the movable element is a piston 215 , The piston 215 includes an elongated push rod 147 extending through the upper section 307 of the piston housing 311 to the opening 115 of the container 313 extends, a piston body 149 that with one end of the push rod 147 is connected and has a size and shape that is designed to be in the lower section 303 of the piston housing 311 to be mobile, and a first sealing ring 143 , around the push rod 147 is held, as well as a second sealing ring 145 that is around the piston body 149 is held around. In the embodiment shown in the figures, the sealing rings have 143 and 145 the shape of circular rubber or plastic rings. However, the sealing rings may be made of any suitable material and may take any form that functions in the device.
  • Regarding 5 to 9 is the basis in this embodiment 151 permanently on the main body 111 attached to a one-piece container 313 train. In this assembled state becomes a first chamber 301 inside the main body 111 defined by the opening 115 to store introduced liquid sample. A second chamber 601 of the main body 111 can also have a cavity section 157 include, in part, the base 151 is defined, and an upper section 211 include to receive the test element. A passage 205 is provided to allow the liquid sample from the first chamber 115 in the second chamber 601 to flow. The passage is sized so that the surface tension of the liquid sample will prevent the sample from flowing from the first to the second chamber until it is transferred from the negative pressure created by depressing the piston in the third chamber to the second chamber. " pulled or sucked in. In the present embodiment, the passage is 205 a hole of small size, as previously mentioned.
  • A third chamber 701 is inside the piston housing 311 defined as in 7 and 9 shown when the piston 215 in the piston housing 311 is received, wherein the first and second sealing ring 143 respectively. 145 serve a seal in the third chamber 701 provide. The third chamber 701 contains a first zone 901 and a second zone 902 wherein the first zone is the area below the movable element and the second zone is the area above the movable element. Therefore, the volume of the first and second zones changes as the movable member is moved from a position to a second position. If present, the seal rings may separate the first zone from the second zone of the third chamber. In the illustrated embodiment, the first zone 901 the space in the third chamber below the second seal ring 145 , and the second zone 902 is the above the first seal ring 145 and below the second seal ring 143 defined space. When the piston 215 in the third chamber 701 moves, remain the first and the second sealing ring 143 . 145 with the inner surface of the upper or lower portion 303 . 307 of the piston housing 311 in contact to provide air communication between the first and second zones 901 . 902 to prevent. The channel 801 allows the passage of air from the second chamber into the third chamber when the movable element in the third chamber is lowered. The channel 801 may take any suitable shape, but is conveniently present as an opening which allows air communication between the second chamber and the third chamber.
  • methods of use
  • In use, a liquid sample, such as. As urine, first introduced into the first chamber of the container. The in the first chamber 115 The liquid sample placed will remain in the first chamber and will not pass through 205 because the surface tension of the liquid sample is sufficient to prevent it from flowing through the passage until it is from one in the second chamber 601 vacuum force is sucked through.
  • The lid 101 will then be on the container 313 coupled, such. B. by screwing the lid on the container. Regarding 7 is the piston 215 at the beginning of the assay (the assay) in a first elevated position. In the first position, the top of the push rod extends 147 in the first chamber a sufficient distance upwards, so that when the lid is applied, the recess 107 in the lid will touch the top of the push rod. The piston body 149 lies in the lower section 303 of the piston housing 311 , In one embodiment, the piston body is located 149 on a number of ribs extending from an inner surface of the intermediate section 305 protrude. When the piston is in the first elevated position, the volume of air is in the second zone 902 the third chamber 701 relatively low in relation to the volume of air in the second zone 902 when the piston body 149 is in the second lowered position.
  • If the lid 101 screwed onto the container, comes the lower surface 201 the circular depression 107 with the top of the push rod 147 in contact and exerts a downward force on the push rod to cause the movement of the piston along its axial direction from the first raised position to the second lowered position. With the movement of the piston from the first position to the second position, air is expelled from the venting hole from the first zone. At the same time, a negative pressure is generated in the second zone, which causes air from the second chamber 601 is "drawn in" into the second zone of the third chamber to fill the vacuum, thereby also creating a corresponding negative pressure in the second chamber 601 containing the liquid sample in the first chamber 115 through the passage 205 in the second chamber 601 "Pulls" to neutralize the vacuum because the vacuum force is sufficient to overcome the surface tension of the liquid sample at the passage, thus causing the liquid sample to pass the test elements in the upper section 211 touched the second chamber. The vent hole may preferably be designed as an opening that allows the passage of air, but may also take any other suitable design that is consistent with its function. Regarding 5 and 6 In one embodiment, it is a barrier wall 163 located directly in the flow path of the liquid coming from the first chamber into the second chamber. This barrier wall 163 serves to transfer a portion of the liquid sample into the second chamber 601 occurs to block and prevents the liquid sample from reaching a flow rate high enough to cause the strips 125 . 137 damaged or she floods. The barrier wall 163 It requires the liquid to turn at a right angle before it touches the test strips, causing the liquid sample to slow down and, in a more orderly fashion, one end of each strip 125 . 137 touched. This facilitates the capillary action of the liquid sample through the test strip to the test line, and a visible result is displayed 129 . 141 shown. The side walls 117 of the container 313 may be transparent or semitransparent to allow visual observation of the stripes through them.
  • If, as in 9 shown the piston 211 moved from the first position to the second position, which has in the second chamber 601 aspirated liquid sample has a volume that sufficiently immerses the test strips but does not cause flooding. The piston 211 can be adjusted during manufacture so that movement from the first position to the second position draws in an appropriate amount of liquid sample. In addition, the first position can also be preset during production, but the second position can be controlled by the user. For example, a marker may be used as an indicator on the edge 113 be provided to indicate that when the lid 111 screwed on this line, the piston has reached the second position. In this embodiment, the second position can be achieved when the lid 101 completely on the container 313 is coupled. Thus, the user can begin the assay in a single step of attaching the lid to the container, and the test can be performed.
  • example 1
  • This example illustrates the general my use of a device of the invention. Water was poured into five devices of the invention designed as urine cups. After one hour, the water sample remained in the first chamber of the cup and did not enter the second chamber by passing the passage. The lids were then attached to the cups, which pushed down the push rod and moved the plunger from the first position to the second position when the lid was applied.
  • To five minutes was observed that water through the passage entered the second chamber. The water sample wetted the Test strips without flooding them. The cup was then in a placed in a barometric container and one for three minutes subjected to barometric pressure of 0.7. No leakage was observed.
  • Example 2
  • This Example illustrates the use of a device of the invention for detecting drugs in human urine using a competitive assay. Thus, a line would be at the Test line occur if no analyte in the sample would be present. A test strip was available to detect the following analytes: THC, Opiates (OPI), PCP and methamphetamine (MET).
  • rehearse of drug-free urine, urine with a -50% cutoff, urine with a + 50% cutoff, and a threefold cutoff were placed. Each sample was washed three times using the invention Device analyzed by placing the urine sample in the beaker and the lid was attached, allowing the examination (assay) started.
  • To five minutes, the results were observed. In the drug-free Urine specimen was on the test line for the three repetitions all analytes observed a bright line, which is good for everyone Analytes indicated a negative result. For the sample with -50% cutoff became one for all three repetitions for all analytes Line observes what a negative result for all analytes indicated. The samples with + 50% cutoff occurred in each of the three Repetitions either no line or a very weak line on, which indicated a positive result for all samples. For the tri-cutoff samples, no line was visible showed a positive result.
  • The Illustratively described herein may be in the absence any element or elements, restriction or restrictions that are not specific here were revealed. The terms and expressions that used are used for the purposes of description and are not restrictive, and there is no intention that the use of such terms and expressions have any equivalents of those shown and features described or their parts, However, it is recognized that various modifications within of the claimed scope of the invention are possible. Thus, it should be understood that although the present invention specifically by various embodiments and optional Features, the skilled person to a modification and modification can use the concepts disclosed here, and that such modifications and changes as within the scope of this invention, as defined by the appended claims is defined.
  • Of the Content of articles, patents and patent applications and all others Documents and electronically available information, which are mentioned or cited here are hereby by Incorporated reference in its entirety to the extent that as if every single publication is specific and individually as incorporated by reference. Applicants reserve the right to choose any and all materials and information from any such articles, patents, patent applications or other documents physically incorporated into this application.
  • QUOTES INCLUDE IN THE DESCRIPTION
  • This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.
  • Cited patent literature
    • US 4976923 [0004]
    • - US 5429804 [0004]
    • US 6726879 [0004]

Claims (11)

  1. Device for detecting the presence of a Analytes in a liquid sample, comprising: an opening for introducing the liquid sample into a first Chamber for collecting the liquid sample; a second Chamber connected to the first chamber through a passage is and contains a test element; one with the second Chamber connected by a channel third chamber, which is a movable Contains element with a first and second position, wherein the third chamber from the movable element into a first and second zone is divided and the first zone a ventilation hole includes; wherein the movable member is at least one Wall of the third chamber is in contact to a gas connection between the first and second zones.
  2. Apparatus according to claim 1, further comprising a lid to close the opening.
  3. The device of claim 1, wherein the test element is an assay card containing one or more test strips.
  4. Apparatus according to claim 1, wherein the movable Element is a piston.
  5. Apparatus according to claim 4, wherein the piston is a Contains gasket that fits with at least one wall of the third chamber is in contact to a gas connection between prevent the first and second zone.
  6. Apparatus according to claim 4, wherein the third chamber includes a floor and the ventilation hole on the floor the third chamber is arranged.
  7. Apparatus according to claim 4, wherein the piston is a comprising an opening extending to the push rod.
  8. Apparatus according to claim 7, further comprising a lid comprising a surface that contacts the push rod and depresses when the lid is on the opening is applied.
  9. The device of claim 1, wherein the passage has a diameter of less than 8 mm.
  10. Apparatus according to claim 9, wherein the passage has a diameter of less than about 4 mm.
  11. The device of claim 1, wherein the test element comprises at least one test strip.
DE212006000063U 2005-10-25 2006-10-20 Device for detecting analytes in liquid samples Expired - Lifetime DE212006000063U1 (en)

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CN200510113977.5 2005-10-25
CNB2005101139775A CN100478671C (en) 2005-10-25 2005-10-25 Detector and method for liquid sampler
US11/260,496 2005-10-26
US11/260,496 US9011770B2 (en) 2005-10-25 2005-10-26 Device for detecting analytes in fluid samples
PCT/GB2006/003910 WO2007049010A1 (en) 2005-10-25 2006-10-20 Device for detecting analytes in fluid samples

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CA (1) CA2624971C (en)
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IL (1) IL191071A (en)
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JP2009513967A (en) 2009-04-02
US20090308185A1 (en) 2009-12-17
EP1963855A1 (en) 2008-09-03
IL191071A (en) 2013-04-30
AU2006307726A1 (en) 2007-05-03
US9011770B2 (en) 2015-04-21
AU2006307726B2 (en) 2012-04-19
CN1834622A (en) 2006-09-20
CN100478671C (en) 2009-04-15
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JP4889743B2 (en) 2012-03-07
US20070092402A1 (en) 2007-04-26

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